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ASTM F3036 Testing of Absorbable Stents

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ASTM F3036 Standard Guide for Testing Absorbable Stents

ASTM F3036 is a standard guide for physical and mechanical characterization of absorbable vascular stents (bioabsorbable scaffolds).Include Axial, bending, torsional, Pulsatile Durability, Radial Loading etc., test. It applies to degradable polymer and/or absorbable metal stents that provide temporary luminal support in coronary and peripheral arteries and degrade over time in vivo. It does not cover non-absorbable stents with absorbable coatings or absorbable stent-grafts (though some principles apply).


Test Principle:

Unlike traditional permanent metallic stents, absorbable stents (or vascular scaffolds) are designed to provide temporary luminal support and then gradually degrade and assimilate into the body. The core principle of ASTM F3036 is to evaluate the time-dependent decline in physical and mechanical characteristics of these devices.

It achieves this by subjecting the stents to specific pre-conditioning (simulated physiological aging and degradation) before performing standard mechanical tests. This ensures that the test results accurately reflect the stent's performance not just at implantation, but throughout its entire intended service life until it is fully absorbed.


Significance and Uses of ASTM F3036:

Absorbable cardiovascular stents provide temporary support for blood vessels, gradually degrade after implantation, and are absorbed by the human body.

The mechanical testing methods for absorbable devices are similar to those for permanent stents. This standard specifies their exclusive pretreatment, operational requirements, and rules for evaluating time-dependent mechanical performance.

During the degradation process of the stent, mechanical performance gradually diminishes. The core requirement is to provide sufficient support during the vascular repair period.

ASTM F3036 Testing of Absorbable Stents


Specific Test Stipulated and test equipment for ASTM F3036:

Test methodsTesting machineStandardMechanical mode
Pulsatile Durability TestVascular Stent Radial Pulsatile Fatigue Testing SystemASTM F2477Dynamic
Axial Loading Durability TestVascular Stent Uniaxial Tension Durability Testing MachineASTM F2942Dynamic
Bending Durability TestVascular Stent Bending Durability TesterASTM F2942Dynamic
Torsional Durability TestVascular Stent Torsion Durability TesterASTM F2942Dynamic
Fatigue-to-FractureMulti‐Axis Fatigue Torsional & Bending testing systemASTM F3211Dynamic
Radial Loading TestUniversal testing machine with Segmented head stent radial loading compression test fixtureASTM F3067Static
Three-Point BendingUniversal testing machine with vascular stent 3 points bending fixtureASTM F2606Static


Related products and device

ASTM F2942 Vascular Stent Uniaxial Tension Durability Testing Machine

Vascular Stent Uniaxial Tension Durability Testing Machine is designed to perform accelerated axial fatigue and durability testing on vascular stents in accordance with ISO 25539 and ASTM F2942 standards, evaluating their long-term structural integrity under cyclic axial loading.

ASTM F2942 Vascular Stent Bending Durability Tester

Vascular Stent Bending Durability Tester is designed to perform accelerated bending fatigue testing on vascular stents in accordance with ISO 25539 and ASTM F2942 standards, evaluating their long-term structural integrity under cyclic bending loading.

ASTM F2942 Vascular Stent Torsion Durability Tester

UTCA-VST6 Vascular Stent Torsion Durability Tester is designed to perform accelerated torsional fatigue testing on vascular stents in accordance with ISO 25539 and ASTM F2942 standards, evaluating their long-term structural integrity under cyclic torsional loading.

ASTM F3211 Multi‐Axis Fatigue Torsional & Bending testing system

Multi‐Axis Fatigue Torsional & Bending testing system understake this task, used to check the torsion and bending, tension test for the Intramedullary lengthening nail/Intramedullary leg lengthening implants nails.

ASTM F2477 Vascular Stent Radial Pulsatile Fatigue Testing System

Radial Pulsatile Accelerated Durability Tester is designed to perform accelerated pulsatile durability testing on vascular implants such as stents or valve frames, in accordance with relevant requirements of ISO 25539 and ASTM F2477.

ASTM F3036 Single column universal testing machine

A single column tensile tester is a sophisticated material testing instrument designed for measuring mechanical properties of various materials under tension, compression, bending, shear, and other loading conditions. As the name suggests, it features a single vertical column supporting a moving crosshead that applies force to test specimens.

ASTM F3067 Segmented head stent radial loading compression test fixture

Segmented head stent radial loading compression test fixture is a specialized designed to evaluate the radial mechanical properties of vascular stents, including radial strength, chronic outward force (COF), collapse pressure, and radial stiffness. Conform with ASTM F3067, ISO 25539-2

ASTM F2606 Three-Point Bending Test fixture for Vascular Stent

Three-Point Bending Test fixture for Vascular Stent is a specialized mechanical testing instrument designed to evaluate the flexural properties of balloon-expandable vascular stents and stent system. Conform with ASTM F2606, ISO 25539-2.

Related Standard

ASTM F2477 Test for in-vitro Pulsatile Durability Testing of Vascular Stents

ASTM F2477 designed to evaluate the long-term fatigue durability and radial cyclic deformation resistance of vascular implants under simulated physiological pulsatile loading conditions. It is crucial for simulating the cyclical stresses these medical devices endure inside human blood vessels. 

ASTM F3067 Radial Loading Test of Vascular Stents

ASTM F3067 establishes in vitro test frameworks to characterize the radial mechanical performance of balloon-expandable vascular stents and self-expanding vascular stents. It quantifies three key indicators: radial strength and collapse pressure for balloon-expandable stents, and chronic outward force (COF) for self-expanding stents.

ASTM F2606 Three-Point Bending Test for Balloon-Expandable Vascular Stents and Stent Systems

ASTM F2606 defines quantitative three-point bending procedures to characterize the bending flexibility and stiffness of balloon-expandable vascular stents and stent systems (pre-deployment and deployed states). It is a critical testing protocol in the biomedical engineering field. Since vascular anatomies are naturally curved and tortuous, a stent must be flexible enough to navigate through the delivery pathway (trackability) and conform to the vessel's curvature once deployed without causing vascular trauma . This standard provides the guidelines to measure these mechanical properties accurately.

ASTM F2942 Vascular Implants Axial, bending, torsional and compression durability testing

ASTM F2942 specifies in vitro test methodologies to evaluate the cyclic durability of vascular stents under non-radial mechanical deformations (axial, bending, and torsion) that occur in vivo due to musculoskeletal motion, breathing, or cardiac activity. 

ISO 17137 Test Methods of cardiovascular absorbable implants

Based on the ISO/TS 17137 standard the evaluation of mechanical properties is a critical part of the design and safety validation process. Mechanical Evaluation like tension, radial force, Cyclic Fatigue Durability like constant pulsing. Because absorbable implants lose their structural integrity over time through degradation, their mechanical performance must be assessed not just at the time of implantation, but throughout their intended functional lifetime. 

ISO 12417-1 Test Methods for Cardiovascular implants and extracorporeal systems

ISO 12417-1 specifies requirements for Vascular Device-Drug Combination Products (VDDCPs) (drug-eluting stents, drug-coated balloons, drug-bearing vascular grafts, etc.). It mandates mechanical tests for the device part (DP) (to verify structural/functional integrity) and a suite of drug-related, physicochemical, biological, and clinical tests. Mechanical performance must comply with device-specific standards (ISO 25539-2, ISO 10555-4, ISO 7198) and remain unaffected by the drug-containing part (DCP). 

ISO 7198 Mechanical Tests and Other Evaluations for Vascular Implants

ISO 7198 specifies test and performance requirements for tubular vascular grafts and vascular patches (surgical vascular prostheses). It defines mechanical tests (with full method/equipment/sample details) and other physicochemical, biological, dimensional, preclinical/clinical tests.

Why is the ASTM F3036 Test Important for the Material?

The test is crucial because absorbable materials behave fundamentally differently from permanent metals like stainless steel or cobalt-chromium.


Predicting In-Vivo Performance: Polymers and absorbable metals undergo hydrolysis or corrosion, causing their molecular weight and mechanical strength to plummet over time. This test ensures the material retains enough structural integrity to support the vessel during the critical healing period (usually 3 to 6 months) before safely degrading.


Uncovering Hidden Failure Modes: Without this specific testing protocol, manufacturers might miss catastrophic issues like stress concentration cracking or accelerated degradation caused by the combination of bodily fluids and cyclic mechanical loading.


Ensuring Patient Safety: By mapping the exact timeline of mechanical decline, clinicians know exactly how long the stent will provide support, ensuring the vessel remains open during remodeling and preventing late-stage complications like stent fracture or vessel re-narrowing (restenosis).

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